1. Technical Field
The present disclosure generally relates to a disposable surgical instrument and, more particularly, to a surgical instrument which can be utilized a limited number of times before being rendered inoperable by the occurrence of at least one instrument-disabling phenomenon.
2. Background of Related Art
Increasingly, surgeons are employing disposable surgical instruments which are designed to be used a limited number of times and thereafter discarded. Many disposable instruments are intended to be employed once in a single surgical operation. Disposable surgical instruments possess a number of advantages over reusable surgical devices, e.g., they can be fabricated from less expensive materials compared to reusable devices and consequently reduce the overall cost of surgery, they perform optimally since they are not subject to the wear and tear of repeated use, and they minimize the risk that infectious diseases will be transmitted to other patients.
It is important, however, to recognize that disposable surgical instruments are often equipped for use in a single procedure, e.g., by reason of a limited number of staples or clips, and are generally not designed to withstand many repeated resterilizations and reuses. For example, surgical staplers, clip appliers, and the like, have been provided with lock-out mechanisms which preclude actuation of the devices after they have been actuated a predetermined number of times. See, e.g., U.S. Pat. No. 4,955,959. Surgical devices which include mechanisms for displaying the number of times the device has been used (U.S. Pat. No. 5,313,935) or the number of times the device has been heated, e.g., by autoclave sterilization (EP0581400), are known.
An endoscope, i.e., an instrument used in surgery to view internal portions of a patient's body, is a long, slender instrument having a shaft which is either rigid or flexible, depending on the procedure being performed, and an optical lens system for focusing on and relaying an illuminated image from inside a body cavity to a physician. Essential optical components of a conventional optical system include a combination of lenses constituting an objective lens for forming a focused real image of an object, a system of relay lenses to carry the image through the endoscope, and an eye lens assembly which produces a magnified virtual image for the viewer. In general, the objective lens is positioned adjacent a distal end and the eye lens assembly is mounted at the proximal end of the endoscope. Endoscopes are commonly equipped with an illumination system, e.g., a fiber optic bundle, which illuminates the area being imaged. Generally, a camera adaptor is provided at the proximal end of the endoscope to permit the image to be displayed on a monitor for viewing by the entire surgical team.
It has been found necessary and advantageous, therefore, to furnish disposable surgical instruments with at least one disabling means which, after being initiated, exerts a disabling effect on the instrument and thereby permanently or temporarily precludes further use of the instrument. It has also been found expedient to furnish a disposable endoscope with disabling means to prevent the endoscope from being used beyond a predetermined number of times.